Study of Velcade and Temsirolimus for Relapsed or Refractory Non-Hodgkin Lymphoma

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The investigators want to find out if the drugs Velcade and temsirolimus given together are effective in treating cancer. Velcade and temsirolimus are each FDA approved individually for certain types of cancer (Velcade for multiple myeloma and mantle cell lymphoma, and temsirolimus for renal cell carcinoma) but are not currently approved in combination for B-cell non-Hodgkin lymphoma. The investigators are trying to find out if giving these 2 drugs together will improve the period of time that the patient's cancer is stopped or slowed from growing and causing symptoms.

The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by overall response rate (ORR) to therapy. ORR is the sum of patients with a Complete Response and Partial Response to therapy. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete REsponse (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Progression Free Survival [ Time Frame: Up to 60 months ]

The primary objective of this study is to determine whether Velcade in combination with temsirolimus provides benefit to subjects with relapsed or refractory B-cell non-Hodgkin lymphoma as assessed by progression-free survival (PFS).

Secondary Outcome Measures :

Safety of This Regimen [ Time Frame: Up to 36 months ]

Safety of the regimen will be measured by frequency and severity of adverse events.

Complete Response Rate [ Time Frame: Up to 60 months ]

The complete response rate (CR) to therapy as defined by International Lymphoma Response Criteria.

Tolerability of the Regimen [ Time Frame: Up to 36 months ]

Tolerability of the regimen is measured by the number of subjects able to complete the therapy as planned.

Duration of Response [ Time Frame: Up to 60 months ]

Duration of Response is how long a response to therapy is held before a subject has progressive disease.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Female subjects must be either post-menopausal for at least 1 year or surgically sterilized, agree to practice 2 effective methods of contraception from the time of signing the informed consent form through 30 days after the last dose of Velcade, or agree to completely abstain from heterosexual intercourse.

Male subjects, even if surgically sterilized (ie, status postvasectomy) must agree to 1 of the following: practice effective barrier contraception during the entire study treatment period and through a minimum of 30 days after the last dose of study drug, or completely abstain from heterosexual intercourse.

Exclusions:

Antineoplastic, experimental, or radiation therapy within 14 days prior to enrollment, or 21 days prior to Day 1 of Cycle 1.

Radioimmunoconjugates within 10 weeks of Day 1 of Cycle 1.

Autologous stem cell transplant within 3 months before Day 1 of Cycle 1, or any prior history of allogeneic stem cell transplant.

Platelet transfusion within 7 days of Day 1 of Cycle 1.

Ongoing therapy with glucocorticoids. Prednisone ≤15 mg per day or its equivalent is allowed.

Patient has Grade 2 or greater peripheral neuropathy within 14 days before enrollment.

Serious medical or psychiatric illness that is likely to interfere with participation

Diagnosed or treated for another malignancy within 2 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, or low-risk prostate cancer after curative therapy.

Prior therapy with both Velcade and temsirolimus. Patients who have previously been treated with either Velcade or temsirolimus (but not both) are eligible.

Radiation therapy within 3 weeks before randomization.

Patients must not be taking the following strong CyP3A inducers at study entry: phenytoin, phenobarbital, rifampin, carbamazepin, rifabutin, rifampicin, a one week washout period is required.